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CardioFlow’s VitaFlow Liberty™ Granted EU CE-MDR Mark, Advancing Global Expansion Roadmap

Coronary/Structural Heart by Comments are Disabled

SHANGHAI, June 17, 2024 /PRNewswire/ — MicroPort® CardioFlow Medtech Corporation (CardioFlow) (Stock Code: 02160.HK) recently announced that its self-developed second-generation transcatheter aortic valve implantation (TAVI) device, the VitaFlow LibertyTM Transcatheter Aortic Valve and Retrievable Delivery System (VitaFlow LibertyTM), has received EU CE-MDR certification. This certification highlights VitaFlow LibertyTM as a pioneering TAVI solution, that sets a new benchmark in transcatheter heart valve treatments.

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VitaFlow_Liberty__Transcatheter_Aortic_Valve_and_Retrievable_Delivery_System

With over 47 million patients globally[1] suffering from aortic valve stenosis and regurgitation, the prevalence rates of these conditions are on the rise due to an aging population. The TAVI solution provided by CardioFlow, which avoids open-heart surgery and offers various benefits like minimal trauma, quick recovery, and enhanced quality of life, is increasingly becoming a preferred choice for patients with aortic heart valve disease.

CardioFlow, one of the world’s leading innovative medical device companies, has entered the field of structural heart disease when the field was still at an early adoption phase. Originating and headquartered in Shanghai, China, CardioFlow was listed on the Hong Kong Stock Exchange on February 2021. The company has a diverse product pipeline resulting from independent and collaborative research, covering structural heart devices such as transcatheter aortic, mitral, and tricuspid valves, left atrial appendage occludes, and accessories. Leveraging its technological expertise and capacity for innovation, the company has successfully obtained approvals and launched several TAVI products globally, among which VitaFlow LibertyTM stands out as the world’s only electric retrievable transcatheter aortic valve system. The VitaFlowTM series TAVI solution along with its accessory – the AlwideTM series Balloon Catheter, has successfully covered nearly 700 core hospitals in 10 countries and regions, treating more than 10,000 patients with aortic valve disease worldwide.
The clinical data from VitaFlowTM series valves were revealed at PCR London Valves 2023, a leading global conference on structural heart diseases. These results highlight VitaFlowTM’s exceptional long-term clinical performance aligning with international top-tier standards. The long-term results of VitaFlowTM in high surgical risk patients with severe aortic stenosis showed promising outcomes in all-cause mortality, cardiac mortality, and permanent pacemaker implantation rates for patients over seven years, compared to other similar studies. During the conference, Dr. Darren Mylotte from Galway University Hospitals, Ireland, commented on the excellent data, and introduced the advantages of VitaFlow LibertyTM in its one of a kind motorized delivery system. The system can assist the valve to position easily due to its flexibility and 360° range of motion when treating complex anatomical patients with severe angled aortic arch deformities. The valve can also be fully retrieved and repositioned when released to 75%, and provides up to 3 retrievable opportunities for each procedure, thereby further optimizing the implantation effect. Additionally, it can effectively ensure the stability of valve release, reduce valve displacement, and make the procedure more controllable.Before launching into the EU market, VitaFlow LibertyTM conducted pre-market clinical implantations at Galway University Hospital in Ireland, Rigshospitalet (Copenhagen University Hospital) in Denmark, and St Thomas’ Hospital as well as Brighton & Sussex University Hospitals NHS Trust in the United Kingdom, and received very high appraisal from many well-known clinical professionals. Dr. Ole De Backer, a professor of interventional cardiology, who led the TAVI procedures at Rigshospitalet stated, “The overall release process of VitaFlow LibertyTM is notably stable, ensuring precise positioning. This stability is especially crucial in patients with a small left ventricles, where VitaFlow LibertyTM consistently achieves stable and precise deployment, fully demonstrating its distinct advantages. We look forward to its positive impact on a broader patient population following CE certification.” It has been reported that the European post-market clinical project will also be planned to start this year.As part of CardioFlow’s global expansion roadmap, the company has also achieved significant milestones with CE application on three of its products, including the AlwideTM Plus Balloon Catheter, an essential accessory for aortic valve procedures, as well as the AnchorManTM Left Atrial Appendage Closure System and the AnchorManTM Left Atrial Appendage Access System, both developed by its subsidiary, CardioAdvent.Jeff Lindstrom, President of CardioFlow, stated, “The certification of VitaFlow LibertyTM by the CE regulatory body under MDR, is a testament to CardioFlow’s world-class R&D, quality, and clinical capabilities. This recognition will expedite the global clinical adoption of the VitaFlowTM series along with other innovative products, advancing CardioFlow’s globalization strategy. This achievement also positions us to make a more substantial contributions to developments in the field of heart valve interventions, ultimately benefiting patients across the globe.”Guoming Chen, Chairman of CardioFlow, commented, “Securing the EU CE-MDR marking for VitaFlow LibertyTM is not just a passport for the product’s entry into the European market, it also represents a significant milestone in CardioFlow’s history and global roadmap. This achievement will assist in diversifying the company’s sources of sales revenue and bolstering our overall competitiveness with a steadfast commitment to world-class product innovation.”

1. Frost & Sullivan’s statistics, 2021

Photo – https://mma.prnewswire.com/media/2440350/VitaFlow_Liberty__Transcatheter_Aortic_Valve_and_Retrievable_Delivery_System.jpg 

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Philips Zenition 90 Motorized receives FDA 510(k) clearance, helping clinicians deliver high quality care with a high-powered and fast motorized mobile C-arm

Radiology by Comments are Disabled

June 17, 2024 Intuitive motorization for greater control and high-power (25 kW [1]) for state-of-the-art image quality supports complex vascular needs and a full range of clinical proceduresAutomated workflows contribute to greater flexibility and independence for clinicians, providing more time to focus on achieving the best possible outcomes for patients Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced the launch of Philips Image Guided Therapy Mobile C-arm System 9000 – Zenition 90 Motorized, designed to help clinicians deliver high-quality care to more patients. Philips is partnering with its customers to improve productivity. The new mobile C-arm with expanded capabilities is designed to meet complex vascular needs, but also a range of clinical procedures such as cardiac interventions, pain management and urology. Philips will be showcasing its newly introduced mobile C-arm at the 2024 Society for Vascular Surgery Annual Meeting, June 19-22, in Chicago. Increased control and efficiency with automated workflowsThe Philips Zenition Image-Guided Therapy Mobile C-arm Systems bring together innovations in image capture and processing, ease-of-use, and versatility, many of which were pioneered on Philips’ highly successful image guided therapy platform Azurion. Motorized and impressively fast, the Zenition 90 Motorized is an intuitive C-arm that allowsclinicians to control it from the table-side with user-friendly controls and time-saving features – empowering the clinician with greater flexibility and independence. It delivers state-of-the-art image quality for the most challenging procedures and is designed to meet complex procedural needs. The system allows greater clinical efficiency thanks to its automated workflows, the image controls via the Touch Screen Module and the advanced software solutions. “During complex procedures, it’s vital to be able to rely on surgical imaging systems. As clinicians navigate their way through challenging anatomy, the priority is to quickly visualize small anatomical details while limiting X-ray dose,” said Mark Stoffels, Business Leader Philips Image Guided Therapy Systems. “The new Zenition 90 Motorized empowers medical teams to confidently perform a wide range of interventions while achieving the best possible outcome for their patients.” In independent hands-on usability studies of clinicians from the US and EU with the Zenition 90 Motorized in simulated environments; 100% of users said that with the Table Side Operator, they have complete control over C-arm movements [2] and 97% report that workflow features such as Automatic Vascular Outlining will help save time during procedures [3].  As part of its commitment to sustainability and providing customers with responsible choices, Philips leveraged its EcoDesign process for the Zenition 90 Motorized to improve product life by 25% and power efficiency by 13% [4]. Philips latest image guided therapy mobile C-arm system is also available in a non-motorized configuration.[1]Also available in 15 kW[2] Results obtained during claims substantiation study performed in June 2022 and May 2023 by Use-Lab GmbH, an independent company. Response is based on 25 physicians from the EU and the US, who answered a questionnaire after a usability study with additional hands-on time with the system.[3] Results obtained during claims substantiation study performed in June 2022 and May 2023 by Use-Lab GmbH, an independent company. Response is based on 49 clinicians from the EU and the US, who answered a questionnaire after a usability study with additional hands-on time with the system.[4] Compared to its predecessor, Zenition 70- Zenition 90 Motorized and Zenition 90 are available for sales in a limited number of countries.- Some features are optional for Zenition 90 Motorized and Zenition 90.- Actual product representation may vary. For further information, please contact:Joost MalthaPhilips External RelationsTel. : +31 6 10558116E-mail: joost.maltha@philips.com About Royal PhilipsRoyal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people’s health and well-being through meaningful innovation. Philips’ patient- and people-centric innovation leverages advanced technology and deep clinical and consumer insights to deliver personal health solutions for consumers and professional health solutions for healthcare providers and their patients in the hospital and the home. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, ultrasound, image-guided therapy, monitoring and enterprise informatics, as well as in personal health. Philips generated 2023 sales of EUR 18.2 billion and employs approximately 69,100 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.
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ISTH 2024 Unveils Late-Breakthrough Abstracts to be Presented in Bangkok, Thailand Showcasing Groundbreaking Science and Research

Peripheral/Endo by Comments are Disabled

International scientific meeting convenes in Bangkok, Thailand, for the first time highlighting the important work of the Asian-Pacific scientific and clinical community
BANGKOK, June 17, 2024 /PRNewswire/ — Today, the International Society on Thrombosis and Haemostasis (ISTH) announces that all ISTH 2024 Congress (June 22-26, 2024) abstracts are available online, including late-breakthrough abstracts, to give a detailed glimpse into the posters, presentations and plenaries that will be presented at the Congress in Bangkok, Thailand.
At the ISTH 2024 Congress, thousands of the world’s leading experts on thrombosis, hemostasis and vascular biology will convene in Bangkok, Thailand, to present the most recent advances, exchange the latest science and discuss the newest clinical applications designed to improve patient care. This marks the Congress’s return to the Asia-Pacific region for the first time since it was held in Kyoto, Japan, in 2011, and its debut in Bangkok.
Through an extensive lineup of educational sessions, poster and oral communications, state-of-the-art lectures, medical industry exhibits and professional networking opportunities, the Congress promotes the latest scientific discourse and advancement in the field.
The following late-breakthrough abstracts will be highlighted during the ISTH 2024 Congress:

Evaluation of recombinant human prourokinase in the treatment of acute pulmonary embolism (ERUPTE): A randomized, single-blinded, multicenter, phase 2 trial, Zhi-Cheng Jing, Guangdong Provincial People’s Hospital, China
Efficacy and safety of Mim8 prophylaxis in adults and adolescents with hemophilia A with or without inhibitors: Phase 3, open-label, randomized, controlled FRONTIER2 study, Maria Elisa Mancuso, IRCCS Humanitas Research Hospital, Italy
EMA601, a novel humanised fab inhibits platelet Glycoprotein VI with unprecedented potency and protects mice from arterial thrombosis and ischemic stroke, Stefano Navarro, University of Würzburg, Germany

To see a full list of the late-breakthrough abstracts that will be presented throughout the Congress, continue reading below.
Sunday, June 23, 2024

Safety, tolerability, and efficacy of mezagitamab (TAK-079) in chronic or persistent primary immune thrombocytopenia: Interim results from a phase 2, randomized, double-blind, placebo-controlled study by David Kuter, Massachusetts General Hospital, United States – Late Breakthrough Session 1.1, 9:30 a.m., Plenary Hall
Engineering FVIII protein for enhancing expression and secretion profile to achieve normal level of FVIII in plasma utilizing noninvasive transcutaneous ultrasound mediated gene delivery by Ivan Krivega, SonoThera, United States – Late Breakthrough Session 1.2, 9:45 a.m., Plenary Hall
Evaluation of recombinant human prourokinase in the treatment of acute pulmonary embolism (ERUPTE): A randomized, single-blinded, multicenter, phase 2 trial, by Zhi-Cheng Jing, Guangdong Provincial People’s Hospital, China – Late Breakthrough Session 1.3, 10:00 a.m., Plenary Hall
EMA601, a novel humanised fab inhibits platelet glycoprotein VI with unprecedented potency and protects mice from arterial thrombosis and ischemic stroke, by Stefano Navarro, University of Würzburg, Germany – Late Breakthrough Session 1.4, 10:15 a.m., Plenary Hall
Efficacy and safety of Mim8 prophylaxis in adults and adolescents with hemophilia A with or without inhibitors: Phase 3, open-label, randomized, controlled FRONTIER2 study, by Maria Elisa Mancuso, IRCCS Humanitas Research Hospital, Italy – Late Breakthrough Session 1.5, 10:30 a.m., Plenary Hall

Due to limited space, the ISTH 2024 Congress will not hold a press conference this year.For more information about the ISTH 2024 Congress, visit www.isth2024.org and for all other media needs, visit the virtual press room: www.isth2024.org/pressroom
About the International Society on Thrombosis and Haemostasis (ISTH)  Founded in 1969, the ISTH is the leading worldwide not-for-profit organization dedicated to advancing the understanding, prevention, diagnosis, and treatment of conditions related to thrombosis and hemostasis. ISTH is an international medical-scientific professional membership organization with more than 7,000 clinicians, researchers, and educators working together to improve the lives of patients in more than 110 countries around the world. Among its highly regarded activities and initiatives are education and standardization programs, clinical and laboratory practice guidelines and guidance, research activities, meetings and congresses, peer-reviewed publications, expert committees, and World Thrombosis Day on 13 October. Visit ISTH online at www.isth.org. 
SOURCE International Society on Thrombosis and Haemostasis

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Longeveron Announces Exercise of Warrants for $4.4 Million Gross Proceeds

Financial by Comments are Disabled

MIAMI, June 17, 2024 (GLOBE NEWSWIRE) — Longeveron Inc. (NASDAQ: LGVN) (“Longeveron” or the “Company”), a clinical stage regenerative medicine biotechnology company developing cellular therapies for rare, life-threatening and chronic aging-related conditions, today announced that it has entered into definitive agreements for the exercise of certain existing warrants to purchase an aggregate of 1,697,891 shares of its Class A common stock having an exercise price of $2.35 per share, originally issued in April 2024. The resale of the shares of Class A common stock issuable upon exercise of the existing warrants is registered pursuant to an effective registration statement on Form S-1 (File No. 333-278995). The gross proceeds to the Company from the exercise of the existing warrants are expected to be approximately $4.4 million, prior to deducting placement agent fees and estimated offering expenses payable by the Company. H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering. In consideration for the immediate exercise of the existing warrants for cash and the payment of $0.125 per new warrant, the Company will issue new unregistered warrants to purchase up to an aggregate of 3,395,782 shares of Class A common stock. The new warrants will be immediately exercisable at an exercise price of $2.50 per share and will have a term of twenty-four months from the date of issuance. The offering is expected to close on or about June 18, 2024, subject to satisfaction of customary closing conditions. The Company intends to use the net proceeds from the offering for its ongoing clinical and regulatory development of Lomecel-B™ for the treatment of several disease states and indications, including HLHS and Alzheimer’s disease, obtaining regulatory approvals, capital expenditures, working capital and other general corporate purposes. The new warrants described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and Regulation D promulgated thereunder and, along with the shares of Class A common stock issuable upon exercise of the new warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the new warrants issued in the private placement and the shares of Class A common stock underlying the new warrants may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. The Company has agreed to file a registration statement with the Securities and Exchange Commission covering the resale of the shares of Class A common stock issuable upon the exercise of the new warrants. This press release does not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. About Longeveron Inc. Longeveron is a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. The Company’s lead investigational product is Lomecel-B™, an allogeneic medicinal signaling cell (MSC) therapy product isolated from the bone marrow of young, healthy adult donors. Lomecel-B™ has multiple potential mechanisms of action encompassing pro-vascular, pro-regenerative, anti-inflammatory, and tissue repair and healing effects with broad potential applications across a spectrum of disease areas. Longeveron is currently pursuing three pipeline indications: hypoplastic left heart syndrome (HLHS), Alzheimer’s disease, and Aging-related Frailty. For more information, visit www.longeveron.com or follow Longeveron on LinkedIn, X, and Instagram. Forward-Looking Statements Certain statements in this press release that are not historical facts are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, which reflect management’s current expectations, assumptions, and estimates of future operations, performance and economic conditions, and involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the statements made herein. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as “believe,” “expects,” “may,” “looks to,” “will,” “should,” “plan,” “intend,” “on condition,” “target,” “see,” “potential,” “estimates,” “preliminary,” or “anticipates” or the negative thereof or comparable terminology, or by discussion of strategy or goals or other future events, circumstances, or effects and include, but are not limited to, the potential for Lomecel-B™ to be a beneficial treatment for patients with HLHS and include, but are not limited to, statements regarding the completion of the private placement, the satisfaction of customary closing conditions related to the private placement and the anticipated use of proceeds from the private placement. Factors that could cause actual results to differ materially from those expressed or implied in any forward-looking statements in this release include, but are not limited to, market and other conditions, adverse global conditions, including macroeconomic uncertainty; inability to raise additional capital necessary to continue as a going concern; our history of losses and inability to achieve profitability going forward; the absence of FDA-approved allogenic, cell-based therapies for HLHS or other cardiac-related indications; ethical and other concerns surrounding the use of stem cell therapy or human tissue; our exposure to product liability claims arising from the use of our product candidates or future products in individuals, for which we may not be able to obtain adequate product liability insurance; the adequacy of our trade secret and patent position to protect our product candidates and their uses: others could compete against us more directly, which could harm our business and have a material adverse effect on our business, financial condition, and results of operations; if certain license agreements are terminated, our ability to continue clinical trials and commercially market products could be adversely affected; the inability to protect the confidentiality of our proprietary information, trade secrets, and know-how; third-party claims of intellectual property infringement may prevent or delay our product development efforts; the inability to successfully develop and commercialize our product candidates and obtain the necessary regulatory approvals; we cannot market and sell our product candidates in the U.S. or in other countries if we fail to obtain the necessary regulatory approvals; final marketing approval of our product candidates by the FDA or other regulatory authorities for commercial use may be delayed, limited, or denied, any of which could adversely affect our ability to generate operating revenues; we may not be able to secure and maintain research institutions to conduct our clinical trials; ongoing healthcare legislative and regulatory reform measures may have a material adverse effect on our business and results of operations; if we receive regulatory approval of Lomecel-B™ or any of our other product candidates, we will be subject to ongoing regulatory requirements and continued regulatory review, which may result in significant additional expense; being subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our therapeutic candidates; reliance on third parties to conduct certain aspects of our preclinical studies and clinical trials; interim, “topline” and preliminary data from our clinical trials that we announce or publish from time to time may change as more data become available and are subject to audit and verification procedures that could result in material changes in the final data; provisions in our certificate of incorporation and bylaws and Delaware law might discourage, delay or prevent a change in control of our company or changes in our management and, therefore, depress the market price of our Class A common stock; we have never commercialized a product candidate before and may lack the necessary expertise, personnel and resources to successfully commercialize any products on our own or together with suitable collaborators; and in order to successfully implement our plans and strategies, we will need to grow our organization, and we may experience difficulties in managing this growth. Further information relating to factors that may impact the Company’s results and forward-looking statements are disclosed in the Company’s filings with the Securities and Exchange Commission, including Longeveron’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the Securities and Exchange Commission on February 27, 2024, as amended by the Annual Report on Form 10-K/A filed March 11, 2024, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. The forward-looking statements contained in this press release are made as of the date of this press release, and the Company disclaims any intention or obligation, other than imposed by law, to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. Investor Contact Derek ColeInvestor Relations Advisory Solutionsderek.cole@iradvisory.com 

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Aerovate Therapeutics Announces 24-Week Topline Results from the Phase 2b Portion of IMPAHCT Evaluating AV-101 for the Treatment of Pulmonary Arterial Hypertension

Coronary/Structural Heart by Comments are Disabled

WALTHAM, Mass., June 17, 2024 (GLOBE NEWSWIRE) — Aerovate Therapeutics, Inc. (Nasdaq: AVTE) today announced topline results from the Phase 2b portion of the Inhaled iMatinib Pulmonary Arterial Hypertension Clinical Trial (IMPAHCT), a Phase 2b/Phase 3, randomized, double-blind, placebo-controlled, multi-national trial of AV-101, a novel dry powder inhaled formulation of imatinib, in adults with pulmonary arterial hypertension (PAH). The objective of the Phase 2b portion of IMPAHCT was to assess the efficacy, safety and tolerability of three different doses of AV-101 compared to placebo. The primary endpoint for the Phase 2b portion of IMPAHCT is change in PVR compared with placebo. Results showed that, while AV-101 was well tolerated across all dose groups, the study did not meet its primary endpoint for improvement in PVR compared to placebo for any of the studied doses or show meaningful improvements in the secondary endpoint of change in six minute walk distance (6MWD). Primary Endpoint – ITT analysis of PVR (dynes*sec/cm^5) DoseLeast-squares mean difference as compared with placebo (95% CI)P value10mg BID (N=50)42.8 (-80.57 to 166.09)0.496835mg BID (N=49)-5.5 (-129.16 to 118.18)0.930670mg BID (N=51)-57.0 (-181.14 to 67.20)0.3685 Secondary Endpoint – ITT analysis of 6MWD (meters) DoseLeast-squares mean difference as compared with placebo (95% CI)10mg BID (N=50)-11.7 (-34.75 to 11.26)35mg BID (N=49)-4.2 (-27.74 to 19.37)70mg BID (N=51)+1.3 (-22.09 to 24.60) The Company has also reviewed data from several additional secondary endpoints of the Phase 2b portion of IMPAHCT, which also failed to show meaningful improvements. Based upon these results, Aerovate, in agreement with the independent study advisory committee, is halting enrollment and shutting down the Phase 3 portion of IMPAHCT as well as the long-term extension study. “The results of the Phase 2b portion of IMPAHCT were unexpected and disappointing. Our immediate focus is on transparently sharing these findings with investigators, patients and the PAH community. In the coming weeks, we will engage closely with the IMPAHCT study advisory committee and the PAH community to thoroughly discuss these data and their implications,” said Tim Noyes, Chief Executive Officer of Aerovate. “We extend our heartfelt gratitude to all trial participants, investigators, and site teams for their dedication to advancing therapeutic options for the treatment of pulmonary arterial hypertension.” Aerovate plans to release full data from the Phase 2b portion of IMPAHCT at a later date, the timing of which is to be determined. As of June 15, 2024, Aerovate has approximately $100 million of cash, cash equivalents and short-term investments. About AV-101AV-101 is an investigational, proprietary dry powder inhaled formulation of the antiproliferative drug imatinib. Developed specifically for pulmonary arterial hypertension (PAH), AV-101 targets cellular hyperproliferation and resistance to apoptosis, driven by improper signaling in cells of the distal pulmonary arteries. AV-101 is designed for delivery by an easy-to-use dry powder inhaler, directly into the lungs to maximize potential clinical benefit and limit systemic adverse effects. About the IMPAHCT TrialIMPAHCT (Inhaled iMatinib Pulmonary Arterial Hypertension Clinical Trial) is a multi-national, placebo-controlled Phase 2b/Phase 3 trial in adults with PAH that continuously enrolled patients from Phase 2b to Phase 3. The Phase 2b portion of the trial evaluated three doses of AV-101 over 24 weeks, compared to placebo, to identify an optimal dose based on the primary endpoint, change in pulmonary vascular resistance (PVR), and safety, tolerability, and other clinical measures. More information about this trial is available at https://clinicaltrials.gov/ct2/show/NCT05036135. About Aerovate Therapeutics, Inc.Aerovate is a clinical stage biopharmaceutical company focused on developing drugs that meaningfully improve the lives of patients with rare cardiopulmonary disease. Aerovate’s initial focus is on advancing AV-101, its proprietary dry powder inhaled formulation of the drug imatinib for the treatment of patients with PAH. Learn more at aerovatetx.com or follow the Company on X (formerly known as Twitter) and LinkedIn. Available InformationAerovate announces material information to the public about the Company, its products and services, and other matters through a variety of means, including filings with the U.S. Securities and Exchange Commission (SEC), press releases, public conference calls, webcasts, the investor relations section of the Company website at ir.aerovatetx.com, and the Company’s X (formerly known as Twitter) account @AerovateTx in order to achieve broad, non-exclusionary distribution of information to the public and for complying with its disclosure obligations under Regulation FD. Cautionary Note Regarding Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements can be identified by words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “future,” “goal,” “intend,” “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” seek,” “strategy,” “should,” “target,” “will,” “would” and similar expressions regarding future periods. These forward-looking statements include, but are not limited to, statements regarding the Phase 2b/Phase 3 IMPAHCT, including the future release of full clinical data and the Company’s plan to halt the Phase 3 portion of the IMPAHCT trial. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the therapeutic potential and clinical benefits of AV-101; the timing associated with the identification and activation of clinical sites, patient enrollment, initiation, delivery of drug supply and continuation of our Phase 2b/Phase 3 trial of AV-101 in PAH patients; the impact of public health crises on our business, clinical trials, operations and goals; positive results from a clinical study may not necessarily be predictive of the results of future or ongoing clinical studies; regulatory developments in the United States and foreign countries; as well as those risks and uncertainties set forth more fully under the caption “Risk Factors” in our most recent Annual Report on Form 10-Q filed with the SEC and subsequent filings with the SEC. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent our views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Media ContactMarites Coultermarites.coulter@vergescientific.com  Investor ContactIR@Aerovatetx.com

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Microbot Medical Announces Brigham and Women’s Hospital as a Site for its Pivotal Human Clinical Trial

Peripheral/Endo by Comments are Disabled

BRAINTREE, Mass., June 17, 2024 (GLOBE NEWSWIRE) — Microbot Medical Inc. (Nasdaq: MBOT) today announces that Brigham and Women’s Hospital (BWH), a leading academic medical center located in Boston, Massachusetts, will participate as a clinical trial site for the pivotal human clinical trial as part of its Investigational Device Exemption (“IDE”) application for its LIBERTY® Endovascular Robotic Surgical System. Dr. Dmitry Rabkin, MD, PhD (Assistant Chief, Division of Angiography & Interventional Radiology) has been selected as principal investigator at BWH. “We are excited to participate in the clinical evaluation of this innovative technology,” said Dr. Rabkin. BWH has completed the Site Initiation Visit, during which BWH clinical staff was trained on the clinical study protocols. In addition, a shipment of LIBERTY investigational units arrived at BWH this week for the clinical trial. “We are pleased to work with Dr. Rabkin and the team at Brigham and Women’s Hospital on this clinical study.” commented Harel Gadot, CEO, President and Chairman of Microbot Medical. “We believe their commitment to research and the advancement of science make them an ideal clinical study site.” The Company is in the process of engaging additional leading centers to participate in the clinical trial. About Microbot Medical Microbot Medical Inc. (NASDAQ: MBOT) is a clinical- stage medical device company that specializes in transformational micro-robotic technologies, with the goals of improving clinical outcomes for patients and increasing accessibility through the natural and artificial lumens within the human body. The Investigational LIBERTY® Endovascular Robotic Surgical System aims to improve the way surgical robotics are being used in endovascular procedures today, by eliminating the need for large, cumbersome, and expensive capital equipment, while reducing radiation exposure and physician strain. The Company believes the LIBERTY® Endovascular Robotic Surgical System’s remote operation has the potential to be the first system to democratize endovascular interventional procedures. Further information about Microbot Medical is available at http://www.microbotmedical.com. Safe Harbor Statements to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for Microbot Medical Inc. and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the Federal securities laws. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects” and “estimates”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, market conditions, risks inherent in the development and/or commercialization of the LIBERTY® Endovascular Robotic Surgical System, the outcome of its studies to evaluate the LIBERTY® Endovascular Robotic Surgical System, uncertainty in the results of pre-clinical and clinical trials or regulatory pathways and regulatory approvals, including whether the Company’s pivotal study in humans is successful, any failure or inability to recruit physicians and clinicians to serve as primary investigators to conduct regulatory studies which could adversely affect or delay such studies, disruptions resulting from new and ongoing hostilities between Israel and the Palestinians and other neighboring countries, any lingering uncertainty resulting from the COVID-19 pandemic, need and ability to obtain future capital, and maintenance of intellectual property rights. Additional information on risks facing Microbot Medical can be found under the heading “Risk Factors” in Microbot Medical’s periodic reports filed with the Securities and Exchange Commission (SEC), which are available on the SEC’s web site at www.sec.gov. Microbot Medical disclaims any intent or obligation to update these forward-looking statements, except as required by law. Investor Contact: Michal Efraty IR@microbotmedical.com

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Peijia Medical Reports Audited 2023 Financial Results and Resumes Trading

Financial by Comments are Disabled

HONG KONG, June 17, 2024 /PRNewswire/ — Peijia Medical (HKG:9996), a leading Chinese domestic player in the high-growth transcatheter valve therapeutic and neurointerventional procedural medical device markets, announced the publication of its audited financial results for the year ended December 31, 2023 (“the period”) on June 16, 2024. Additionally, the Company announced that it would resume trading on the Hong Kong Stock Exchange on June 17, 2024.
“We are pleased to be reporting an exceptional year for Peijia and are eager for our investors to have access to the public markets once again,” said Dr. Yi Zhang, Chairman and CEO of Peijia Medical. “The preliminary, unaudited results published on March 28, 2024 remain unchanged following the audit, reiterating revenue growth of 75.9% and significant increases to our operational efficiencies. Our success was driven by market share gains, product portfolio expansion and key strategic partnerships. I’m very proud of our team and all that we were able to accomplish in 2023 and look forward to leveraging that momentum for the remainder of 2024.”
On March 28, 2024, Peijia announced a delay in the filing of the Company’s 2023 Annual Report as a result of the auditor’s work on certain financial assets, specifically related to the valuation of a prior HK$80million investment by the Company. On April 2, 2024, trading in Peijia shares was suspended pending publication of audited results. According to the Company’s announcement on June 16, 2024, the audit of the 2023 Annual Results have been completed in accordance with International Standards on Auditing issued by the International Auditing and Assurance Standards Board and the Company’s auditor, PricewaterhouseCoopers, have expressed unqualified opinion in the independent auditor’s report.
Trading resumed on June 17, 2024.
Financial Highlights
During the period, the Company recorded an operating revenue of RMB441.1 million, representing an increase of 75.9% year-over-year. The increase in revenue was mainly attributable to:
(i)  the terminal implantation volume of the Company’s TAVR products was 2,484 units, which is more than double the implantation volume in 2022. This has allowed the Company to achieve an over 20% share of the Chinese TAVR market;
(ii)  first-and second-generation TAVR products were utilized in approximately 200 new hospitals, bringing total penetration to nearly 500 hospitals;
(iii)  sales volume of coil products increased significantly as a result of the implementation of VBPs in the provinces where the Company had won bids, especially the 21-province alliance VBP led by Jilin province;
(iv)  sales volume of our existing and newly approved ischemic and vascular access products increased significantly as a result of the professional marketing activities and the quick penetration of neurointerventional procedures following the construction of stroke centers.
During the period, the Company recorded a gross profit of RMB325.4 million, representing an increase of 84.7% over the prior year, driven by continuous cost improvement measures throughout the business. 2023 gross profit margin of 73.8% increased by 350 basis points over the prior year. Expense ratios for selling and distribution, administrative costs, and research and development improved year over year by 22.7%, 17.1% and 82.2%, respectively. 
Financial and Business Results by Segment:
Transcatheter Valve Therapeutic (“TVT”) Business:
During the period, the TVT Business recorded revenue of RMB185.6 million, representing an increase of 72.9% year-over-year. Gross profit increased 86.0% to RMB159.0 million year-over-year. The segment’s gross profit margin was 85.7%, representing an increase of 6.0% year-over-year, driven by supply chain optimization and yield rate improvement. TVT selling and distribution expenses, administrative expenses and research and development expenses ratios decreased by 32.5%, 25.9% and 169.5%, respectively. The segment loss narrowed by 13.5% year-over-year.
With the recovery of procedure volume in the market and the increase in unit production of the sales team, implantation volume of the Company’s TAVR products have increased significantly, leading to further gains in market share. During the period, the Company’s first-and second-generation TAVR products were utilized in approximately 200 new hospitals, bringing total penetration to nearly 500 hospitals. During the year, the terminal implantation volume of the Company’s TAVR products was 2,484 units, which is more than double the implantation volume in 2022. This has allowed us to achieve an over 20% share of the Chinese transfemoral TAVR market.
During the period, the Company made significant progress in the research and development of pipeline products.
In aortic valve product line, the Company expedited the registration clinical trials for TaurusTrio the in-licensed JenaValve Trilogy Transcatheter Heart Valve (“THV”) System designed for pure aortic regurgitation (AR), and TaurusNXT, the Company’s internally developed third-generation durability-enhanced TAVR product. As of June 16, 2024, patient enrollment has been completed for both trials and patient follow-up is ongoing. Specially, in July 2023, the Company launched the multi-center registration clinical trial for TaurusTrio, enrolling a total of 116 AR patients in six months and finished ahead of enrollment schedule targets. In addition, the Company has successfully completed the technology transfer from JenaValve and established local manufacturing facilities at its new headquarters in Suzhou to produce the product independently.
In the mitral and tricuspid valve product lines, the Company has been steadily advancing the research and development progress of each product. The registration clinical trial for GeminiOne, the Company’s internally developed Transcatheter Edge-to-Edge Repair device, was progressing as planned with patient enrollment completed in May 2024. In addition, in October 2023, the early clinical findings of GeminiOne and the novel TTVR product MonarQ were presented at the 2023 Transcatheter Cardiovasvular Therapeutics (“TCT”) conference with preparations now being made to conduct early feasibility studies in the United States.
Operationally, in December 2023, TVT production facilities were relocated to new headquarters, increasing the current manufacturing capacity by three times.
Neurointerventional (“NI”) Business:
During the period, the NI Business recorded revenue of RMB255.6 million, representing a better-than-expected year-over-year increase of 78.1%. Gross profit for the segment increased 83.4% year-over-year to RMB166.4. Gross profit margin improved to 65.1% for the full year, an increase of 190 basis points over 2022. Hemorrhagic, ischemic and vascular access products accounted for 32.0%, 33.6% and 34.1% of the segment revenue, a much more balanced product sales mix over 2022 with 39.4%, 27.6% and 32.9%, respectively. With the increasing sales of ischemic products, the segment’s gross profit margin increased to 67.1%, an increase of 3.5% over the prior year. These gains were driven by coil products winning bids and quick market penetration of new and existing ischemic products.
Selling and distribution expenses, administrative expenses and research and development expenses ratios improved year-over-year by 14.2%, 9.9% and 15.7%, respectively. Also, due to the increase in revenue and gross profit, and the Company’s long-term efforts in cost reduction and efficiency improvement, the segment loss significantly narrowed by 98.8% year-over-year, with the expectation of reaching profitability in 2024.
About the Company
Peijia Medical (09996.HK) was established in 2012 and is headquartered in Suzhou, China. Peijia Medical focuses on the high-growth interventional procedural medical device market in China and aims to become a world-renowned medical device platform that provides comprehensive treatment solutions for structural heart and neurovascular diseases. The Company now has two generations of TAVR systems and sixteen neurointerventional devices commercialized in China and various innovative product candidates at different stage of development. For more information about Peijia visit peijiamedical.com/about. 
SOURCE Peijia Medical

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Centers for Medicare & Medicaid Services (CMS) Issues ICD-10-PCS Codes for Humacyte’s Human Acellular Vessel™ (HAV™)

Financial by Comments are Disabled

– Four unique ICD-10-PCS codes, effective October 1, 2024, for replacement of arteries in the upper and lower extremities using Humacyte’s HAV – – BLA submission under Priority Review by FDA for the treatment of vascular trauma, supported by Phase 2/3 clinical trial results and real-world use treating wartime trauma injuries in Ukraine – DURHAM, N.C., June 17, 2024 (GLOBE NEWSWIRE) — Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, Human Acellular Vessels (HAVs) at commercial scale, today announced the issuance of four new ICD-10-PCS codes by the U.S. Centers for Medicare & Medicaid Services (CMS) ICD-10 Coordination and Maintenance (C&M) Committee. These codes, effective for hospital discharges beginning October 1, 2024, cover procedures for replacing arteries in the upper or lower extremities using Humacyte’s HAV. Humacyte also announced that, based on guidance from the Food and Drug Administration (FDA), the common (non-brand) name for the HAV will be the “acellular tissue engineered vessel” (ATEV). The CMS ICD-10 C&M Committee issues ICD-10-PCS codes to facilitate accurate classification and tracking of procedures. The ICD-10-PCS is a classification for procedures performed during inpatient hospital admissions1. The codes are widely used by hospitals and insurers to support data collection, payment, and monitoring. Obtaining these codes marks a significant milestone as Humacyte advances toward submission of a New Technology Add-on Payment (NTAP) application to CMS planned for later in 2024. Obtaining an ICD-10-PCS code is necessary to file an NTAP application. The newly issued codes are: X2R50WA: Replacement of Right Upper Extremity Artery using Bioengineered Human Acellular Vessel, Open Approach, New Technology Group 10 X2R60WA: Replacement of Left Upper Extremity Artery using Bioengineered Human Acellular Vessel, Open Approach, New Technology Group 10 X2R70WA: Replacement of Right Lower Extremity Artery using Bioengineered Human Acellular Vessel, Open Approach, New Technology Group 10 X2R80WA: Replacement of Left Lower Extremity Artery using Bioengineered Human Acellular Vessel, Open Approach, New Technology Group 10 The ATEV is designed for urgent arterial repair following extremity vascular trauma when synthetic graft is not indicated, and when autologous vein use is not feasible. ATEVs, which are bioengineered human tissues, are under investigation as universally implantable vascular replacements that resist infection and do not require immune suppression. The ATEV is intended to be readily available – “off-the-shelf” – with the potential to save valuable time for surgeons, thereby improving patient outcomes and reducing complications. Humacyte has extensive experience with the ATEV, accumulating over 1,200 patient-years of worldwide use in clinical trials for vascular trauma repair, arteriovenous access for hemodialysis, and peripheral artery disease. The company’s manufacturing facilities are capable of producing ATEVs at commercial scale to meet the potential needs of thousands of patients. The Prescription Drug User Fee Act (PDUFA) date for the FDA’s regulatory decision on Humacyte’s Biologics License Application (BLA), is August 10, 2024. This is based on a Priority Review which was granted by the FDA. The BLA submission was supported by positive results from the V005 Phase 2/3 clinical trial, and real-world evidence from the treatment of wartime injuries in Ukraine. In these studies, Humacyte’s ATEV demonstrated higher patency (blood flow) rates and lower amputation and infection rates as compared to historic synthetic graft benchmarks. The ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency. About Humacyte Humacyte, Inc. (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s initial product candidates, a portfolio of ATEVs, are currently in late-stage clinical trials targeting multiple vascular applications, including vascular trauma repair, arteriovenous (AV) access for hemodialysis, and peripheral artery disease. Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s RMAT designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma also has received an RMAT designation. The ATEV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com. Forward-Looking Statements This press release contains forward-looking statements that are based on beliefs and assumptions and on information currently available. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties, and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this press release include, but are not limited to, the expected PDUFA date; the statements regarding the initiation, timing, progress, and results of our preclinical and clinical trials; the anticipated characteristics and performance of our ATEVs; our ability to successfully complete, preclinical and clinical trials for our ATEVs; the anticipated benefits of our ATEVs relative to existing alternatives; the anticipated commercialization of our ATEVs and our ability to manufacture at commercial scale; the implementation of our business model and strategic plans for our business; the timing or likelihood of regulatory filings, acceptances and approvals, including the BLA for our V005 clinical trial and the NTAP application to CMS; timing, scope, and rate of reimbursement for our ATEVs; and our estimated available market opportunity. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of significant risks and uncertainties that could cause actual results to differ materially from expected results, including, among others, changes in applicable laws or regulations, the possibility that Humacyte may be adversely affected by other economic, business, and/or competitive factors, and other risks and uncertainties, including those described under the header “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023, filed by Humacyte with the SEC, and in future SEC filings. Most of these factors are outside of Humacyte’s control and are difficult to predict. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. Except as required by law, we have no current intention of updating any of the forward-looking statements in this press release. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release. Humacyte Investor Contact:Joyce AllaireLifeSci Advisors LLC+1-617-435-6602jallaire@lifesciadvisors.cominvestors@humacyte.com Humacyte Media Contact:Rich LuchettePrecision Strategies+1-202-845-3924rich@precisionstrategies.commedia@humacyte.com ________________________1 Centers for Medicare & Medicaid Services. (2024). ICD-10-PCS Official Guidelines for Coding and Reporting 2025. Retrieved from https://www.cms.gov/files/document/2025-official-icd-10-pcs-coding-guidelines.pdf

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Elutia Announces FDA Clearance of EluPro®: The First Antibiotic-Eluting BioEnvelope Designed to Protect Patients with Implantable Cardiac Pacemakers and Defibrillators

Rhythm by Comments are Disabled

EluPro becomes the only drug-eluting biologic envelope to receive FDA clearance in the $600 million U.S. implantable electronic device protection market EluPro also granted clearance for indications beyond CIEDs, including neurostimulators and neuromodulators used for pain management, epilepsy, incontinence, and sleep apnea SILVER SPRING, Md., June 17, 2024 (GLOBE NEWSWIRE) — Elutia Inc. (Nasdaq: ELUT) (“Elutia” or the “Company”), a pioneer in drug-eluting biomatrix products, today announced that its Antibiotic-Eluting BioEnvelope, EluPro® (referred to as CanGaroo®RM during development), has received clearance from the U.S. Food and Drug Administration (FDA). Specifically designed to prevent post-operative complications for devices such as pacemakers and defibrillators, EluPro incorporates powerful antibiotic therapy combined with advanced tissue engineering to create a BioEnvelope that over time regenerates into a protective pocket of the patient’s own tissue. Infection, migration, and skin erosion are some of the most frequently encountered complications of pacemaker surgery, occurring in up to five to seven percent of cases. These cause significant patient morbidity and mortality, increase the length of hospitalization, and can add more than $50,000 to healthcare costs per event. In development since 2019 and protected by intellectual property extending beyond 2032, EluPro is the only biologic offering in the $600 million U.S. implantable electronic device protection market. The Company also announced that EluPro was granted clearance for indications beyond the cardiac implantable electronic devices (CIEDs), including neurostimulators and neuromodulators used for pain management, epilepsy, incontinence, and sleep apnea. These additional markets, estimated to be $8 billion worldwide, have not previously been served by a drug-eluting biomatrix and present significant additional growth opportunities for EluPro. “When I implant a pacemaker or defibrillator, minimizing the risk of any future complications is crucial,” said Dr. Benjamin D’Souza, Associate Professor of Medicine at the University of Pennsylvania and Section Chief of Cardiac Electrophysiology at Penn Presbyterian Medical Center. “However, the body’s natural immunity can treat the device like a foreign object contributing to inflammation, causing device migration, potentially eroding through the skin, or sometimes causing a serious infection. Those are the specific problems EluPro was designed to solve. It combines the remodeling properties of regenerative medicine through extracellular matrix along with long-acting antibiotic delivery to create a healthy environment for every device implantation.” The EluPro BioEnvelope is constructed from reinforced layers of natural extracellular tissue matrix and designed to create a conforming envelope with optimal stability for implantable electronic devices. The walls of EluPro are embedded with powerful antibiotics rifampin and minocycline, engineered for extended delivery directly into the surgical site long after closure. This unique combination of drug and biomatrix supports the regeneration of a healthy, vascularized pocket from the patient’s own tissue, mitigating a long-term foreign body response. “Post-operative infection, migration and erosion can result in significant morbidity and mortality for patients receiving a pacemaker or defibrillator. That is why we developed the antibiotic-eluting BioEnvelope,” said Dr. Randy Mills, Elutia’s Chief Executive Officer. “While the approval of EluPro is a major value inflection for Elutia, we believe it is just the tip of the iceberg. We have created a platform to protect patients from the foreign body response that can inevitably develop with any long-term implantable device. We intend to rapidly extend our product offering to other indications as we fulfill our mission to humanize medicine so patients can thrive without compromise.” EluPro represents a significant opportunity in the $600 million U.S. implantable electronic device protection market, previously served by a single competitor. With over 600,000 devices implanted in the U.S. annually, EluPro addresses significant complications arising from these procedures. Elutia plans to launch EluPro into the CIED market nationwide in the second half of 2024 and is prioritizing adjacent markets in the neurostimulation and modulation space, where implantable medical devices result in high rates of addressable complications. About Elutia Elutia develops and commercializes drug-eluting biomatrix products to improve compatibility between medical devices and the patients who need them. With a growing population in need of implantable technologies, Elutia’s mission is humanizing medicine so patients can thrive without compromise. For more information, visit www.Elutia.com. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements can be identified by words such as “projects,” “may,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential,” “promise,” “opportunity” or similar references to future periods. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including any statements regarding EluPro’s potential future success in the CIED protection market or in device protection for other types of implantable devices, like neurostimulators or neuromodulators, and statements regarding market size. These forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to us. Such beliefs and assumptions may or may not prove to be correct. Additionally, such forward-looking statements are subject to a number of known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied in the forward-looking statements, including, but not limited to the following: our ability to continue as a going concern; the risk of product liability claims and our ability to obtain or maintain adequate product liability insurance; our ability to defend against the various lawsuits related to our recalled FiberCel and other viable bone matrix products and avoid a material adverse financial consequence from those lawsuits; our ability to achieve or sustain profitability; our ability to enhance our products, expand our product indications and develop, acquire and commercialize additional product offerings; our dependence on our commercial partners and independent sales agents to generate a substantial portion of our net sales; our dependence on a limited number of third-party suppliers and manufacturers, which, in certain cases are exclusive suppliers for products essential to our business; our ability to successfully realize the anticipated benefits of the November 2023 sale of our Orthobiologics business; physician awareness of the distinctive characteristics, benefits, safety, clinical efficacy and cost-effectiveness of our products; the continued and future acceptance of our products by the medical community; our ability to compete against other companies, most of which have longer operating histories, more established products and/or greater resources than we do; pricing pressure as a result of cost-containment efforts of our customers, purchasing groups, third-party payors and governmental organizations could adversely affect our sales and profitability; and our ability to obtain, maintain and adequately protect our intellectual property rights; and other important factors which can be found in the “Risk Factors” section of Elutia’s public filings with the Securities and Exchange Commission (“SEC”), including Elutia’s Annual Report on Form 10-K for the year ended December 31, 2023, as such factors may be updated from time to time in Elutia’s other filings with the SEC, including Elutia’s Quarterly Reports on Form 10-Q, accessible on the SEC’s website at www.sec.gov and the Investor Relations page of Elutia’s website at https://investors.elutia.com. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. Any forward-looking statement made by Elutia in this press release is based only on information currently available and speaks only as of the date on which it is made. Except as required by applicable law, Elutia expressly disclaims any obligations to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. Investors:Matt SteinbergFINN Partnersmatt.steinberg@finnpartners.com

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Cytokinetics Announces Initiation of Phase 1 Study of Aficamten in Healthy Japanese Participants

Coronary/Structural Heart by Comments are Disabled

SOUTH SAN FRANCISCO, Calif., June 17, 2024 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the first participants have been dosed in a Phase 1 study evaluating the pharmacokinetics, safety and tolerability of aficamten in healthy Japanese and Caucasian participants. “We are conducting this Phase 1 bridging study to characterize the pharmacokinetics of aficamten in healthy Japanese adults and to gather evidence that we believe will be required for potential approval in Japan,” said Fady I. Malik, M.D., Ph.D., Cytokinetics’ Executive Vice President of Research & Development. “In parallel, we are continuing to execute on our later-stage global clinical development program for aficamten alongside preparing regulatory submissions in the U.S. and Europe which we expect to submit this year.” Phase 1 Clinical Trial Design The primary objective of this Phase 1 double-blind, randomized, placebo-controlled study is to evaluate the pharmacokinetics of aficamten following administration of single ascending doses and multiple doses in 70 healthy Japanese and Caucasian participants. The secondary objective is to evaluate the safety and tolerability of aficamten in healthy Japanese and Caucasian participants. The study will enroll four cohorts including three single-ascending cohorts and one multiple dose cohort. Cohorts 1, 2 and 3 will enroll 10 Japanese participants and 10 Caucasian participants each, randomized on an 8:2 basis to receive single-ascending doses of aficamten (5 mg, 10 mg and 20 mg, respectively) or placebo. Enrollment of Cohort 2 and Cohort 3 will commence upon evaluation of the safety of the preceding Cohort. Following the completion of the single ascending dose cohorts, Cohort 4 will enroll 10 healthy Japanese participants randomized on an 8:2 basis to receive single doses of aficamten (5 mg) or placebo, once daily for 14 days. About Aficamten Aficamten is an investigational selective, small molecule cardiac myosin inhibitor discovered following an extensive chemical optimization program that was conducted with careful attention to therapeutic index and pharmacokinetic properties and as may translate into next-in-class potential in clinical development. Aficamten was designed to reduce the number of active actin-myosin cross bridges during each cardiac cycle and consequently suppress the myocardial hypercontractility that is associated with hypertrophic cardiomyopathy (HCM). In preclinical models, aficamten reduced myocardial contractility by binding directly to cardiac myosin at a distinct and selective allosteric binding site, thereby preventing myosin from entering a force producing state. The development program for aficamten is assessing its potential as a treatment that improves exercise capacity and relieves symptoms in patients with HCM as well as its potential long-term effects on cardiac structure and function. Aficamten was evaluated in SEQUOIA-HCM (Safety, Efficacy, and Quantitative Understanding of Obstruction Impact of Aficamten in HCM), a positive pivotal Phase 3 clinical trial in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM). Aficamten received Breakthrough Therapy Designation for the treatment of symptomatic obstructive HCM from the U.S. Food & Drug Administration (FDA) as well as the National Medical Products Administration (NMPA) in China. Cytokinetics expects to submit a New Drug Application (NDA) to the FDA in Q3 2024 and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in Q4 2024. Aficamten is also currently being evaluated in MAPLE-HCM, a Phase 3 clinical trial of aficamten as monotherapy compared to metoprolol as monotherapy in patients with obstructive HCM, ACACIA-HCM, a Phase 3 clinical trial of aficamten in patients with non-obstructive HCM, and CEDAR-HCM, a clinical trial of aficamten in a pediatric population with obstructive HCM, and FOREST-HCM, an open-label extension clinical study of aficamten in patients with HCM. About Cytokinetics Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility. Cytokinetics is preparing regulatory submissions for aficamten, its next-in-class cardiac myosin inhibitor, following positive results from SEQUOIA-HCM, the pivotal Phase 3 clinical trial in obstructive hypertrophic cardiomyopathy. Cytokinetics is also developing omecamtiv mecarbil, a cardiac muscle activator, in patients with heart failure. Additionally, Cytokinetics is developing CK-586, a cardiac myosin inhibitor with a mechanism of action distinct from aficamten, for the potential treatment of HFpEF, and CK-136, a cardiac troponin activator for the potential treatment HFrEF and other types of heart failure, such as right ventricular failure resulting from impaired cardiac contractility. Cytokinetics continues its longstanding history of pioneering innovation in muscle biology and related pharmacology focused to diseases of muscle dysfunction and conditions of muscle weakness. For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on X, LinkedIn, Facebook and YouTube. Forward-Looking Statements This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Cytokinetics disclaims any intent or obligation to update these forward-looking statements and claims the protection of the Act’s Safe Harbor for forward-looking statements. Examples of such statements include, but are not limited to, statements express or implied relating to the properties or potential benefits of aficamten or any of our other drug candidates, our ability to file a new drug application for aficamten with FDA in third quarter 2024, our ability to file a marketing authorization application for aficamten with EMA in the fourth quarter 2024, our ability to obtain regulatory approval for aficamten for the treatment of obstructive hypertrophic cardiomyopathy or any other indication from FDA or any other regulatory body in the United States or abroad, and the labeling or post-marketing obligations that may be required by FDA or any other regulatory body in the United States or abroad as a condition to regulatory approval. Such statements are based on management’s current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to the risks related to Cytokinetics’ business outlines in Cytokinetics’ filings with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and Cytokinetics’ actual results of operations, financial condition and liquidity, and the development of the industry in which it operates, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that Cytokinetics makes in this press release speak only as of the date of this press release. Cytokinetics assumes no obligation to update its forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release. Contact:Cytokinetics Diane WeiserSenior Vice President, Corporate Affairs(415) 290-7757

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